Brief Summary
RATIONALE: Studying quality of life in breast cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future breast cancer survivors.
PURPOSE: This clinical trial is studying quality of life in female breast cancer survivors and their spouse, partner, or acquaintance.
PURPOSE: This clinical trial is studying quality of life in female breast cancer survivors and their spouse, partner, or acquaintance.
Brief Title
Quality of Life in Female Breast Cancer Survivors and Their Spouse, Partner, or Acquaintance
Detailed Description
OBJECTIVES:
* Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of female breast cancer survivors who were age 45 or younger at the time of diagnosis with the quality of life of female breast cancer survivors who were age 55 to 70 at time of diagnosis (considering type of surgical treatment \[lumpectomy vs mastectomy\], hormonal treatments, and time since diagnosis as covariates) and age-matched (to the younger group) females with no history of breast cancer.
* Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of partners of breast cancer survivors who were age 45 or younger at time of diagnosis with the quality of life of partners of breast cancer survivors who were age 55 to 70 at diagnosis and partners of age-matched (to the younger group) females with no history of breast cancer.
* Test and compare quality of life models that identify the variables that mediate between antecedent variables of personal characteristics, diagnostic and treatment characteristics, and quality of life outcomes in order to determine where interventions to improve quality of life should be targeted.
* Explore the relationship of partner antecedent, mediating, and outcome variables as predictors or mediators of outcome variables for breast cancer survivors.
OUTLINE: This is a multicenter study.
Patients, spouse or partner of patients, age-matched acquaintances of patients, and partner of acquaintances complete questionnaires over 60-90 minutes about personal characteristics, self-efficacy, coping, social support, health care provider communication, physical, psychological, social, and spiritual functioning, and quality of life. After completing the study questionnaires, patients and age-matched acquaintances of patients are interviewed via telephone over 30 minutes for cognitive function assessment. A random subset of patients and spouses/partners of patients are interviewed via telephone over 45-60 minutes, using data-generating and open-ended questions, regarding physical functioning, sexual and reproductive issues, psychological issues, social impact, and methods used to deal with breast cancer survivor concerns.
Disease and treatment characteristics of patients are obtained from medical records.
PROJECTED ACCRUAL: A total of 2,697 patients, spouse or partner of patients, age-matched female acquaintances of patients, and partner of acquaintances will be accrued for this study.
* Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of female breast cancer survivors who were age 45 or younger at the time of diagnosis with the quality of life of female breast cancer survivors who were age 55 to 70 at time of diagnosis (considering type of surgical treatment \[lumpectomy vs mastectomy\], hormonal treatments, and time since diagnosis as covariates) and age-matched (to the younger group) females with no history of breast cancer.
* Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of partners of breast cancer survivors who were age 45 or younger at time of diagnosis with the quality of life of partners of breast cancer survivors who were age 55 to 70 at diagnosis and partners of age-matched (to the younger group) females with no history of breast cancer.
* Test and compare quality of life models that identify the variables that mediate between antecedent variables of personal characteristics, diagnostic and treatment characteristics, and quality of life outcomes in order to determine where interventions to improve quality of life should be targeted.
* Explore the relationship of partner antecedent, mediating, and outcome variables as predictors or mediators of outcome variables for breast cancer survivors.
OUTLINE: This is a multicenter study.
Patients, spouse or partner of patients, age-matched acquaintances of patients, and partner of acquaintances complete questionnaires over 60-90 minutes about personal characteristics, self-efficacy, coping, social support, health care provider communication, physical, psychological, social, and spiritual functioning, and quality of life. After completing the study questionnaires, patients and age-matched acquaintances of patients are interviewed via telephone over 30 minutes for cognitive function assessment. A random subset of patients and spouses/partners of patients are interviewed via telephone over 45-60 minutes, using data-generating and open-ended questions, regarding physical functioning, sexual and reproductive issues, psychological issues, social impact, and methods used to deal with breast cancer survivor concerns.
Disease and treatment characteristics of patients are obtained from medical records.
PROJECTED ACCRUAL: A total of 2,697 patients, spouse or partner of patients, age-matched female acquaintances of patients, and partner of acquaintances will be accrued for this study.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Breast Cancer
Cancer Survivor
Cognitive/Functional Effects
Psychosocial Effects of Cancer and Its Treatment
Sexuality and Reproductive Issues
Spiritual Concerns
Eligibility Criteria
DISEASE CHARACTERISTICS:
* Patient
* Female breast cancer survivor with age at initial diagnosis in 1 of the following ranges:
* 18 to 45
* 55 to 78
* Must have enrolled and participated in ECOG study CLB-9741, E-1199, or E-2197
* Must have received chemotherapy at least 3 years, but no more than 8 years prior to this study entry
* Disease free at the time of this study entry
* Spouse or partner of the patient, age-matched female acquaintances of the patient (in the younger patient group), or partner of acquaintances
* Spouse or partner of the patient may be either gender
* Age-matched female acquaintance is defined as within 5 years of age difference of the patient in younger group (18-45 years of age)
* With a similar level of education and race of the patient
* Not a personal friend of the patient
* No history of breast cancer
PATIENT CHARACTERISTICS:
* Must reside in the continental U.S. and speak English (for patients)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Patient
* Female breast cancer survivor with age at initial diagnosis in 1 of the following ranges:
* 18 to 45
* 55 to 78
* Must have enrolled and participated in ECOG study CLB-9741, E-1199, or E-2197
* Must have received chemotherapy at least 3 years, but no more than 8 years prior to this study entry
* Disease free at the time of this study entry
* Spouse or partner of the patient, age-matched female acquaintances of the patient (in the younger patient group), or partner of acquaintances
* Spouse or partner of the patient may be either gender
* Age-matched female acquaintance is defined as within 5 years of age difference of the patient in younger group (18-45 years of age)
* With a similar level of education and race of the patient
* Not a personal friend of the patient
* No history of breast cancer
PATIENT CHARACTERISTICS:
* Must reside in the continental U.S. and speak English (for patients)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Inclusion Criteria
DISEASE CHARACTERISTICS:
* Patient
* Female breast cancer survivor with age at initial diagnosis in 1 of the following ranges:
* 18 to 45
* 55 to 78
* Must have enrolled and participated in ECOG study CLB-9741, E-1199, or E-2197
* Must have received chemotherapy at least 3 years, but no more than 8 years prior to this study entry
* Disease free at the time of this study entry
* Spouse or partner of the patient, age-matched female acquaintances of the patient (in the younger patient group), or partner of acquaintances
* Spouse or partner of the patient may be either gender
* Age-matched female acquaintance is defined as within 5 years of age difference of the patient in younger group (18-45 years of age)
* With a similar level of education and race of the patient
* Not a personal friend of the patient
* No history of breast cancer
PATIENT CHARACTERISTICS:
* Must reside in the continental U.S. and speak English (for patients)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Patient
* Female breast cancer survivor with age at initial diagnosis in 1 of the following ranges:
* 18 to 45
* 55 to 78
* Must have enrolled and participated in ECOG study CLB-9741, E-1199, or E-2197
* Must have received chemotherapy at least 3 years, but no more than 8 years prior to this study entry
* Disease free at the time of this study entry
* Spouse or partner of the patient, age-matched female acquaintances of the patient (in the younger patient group), or partner of acquaintances
* Spouse or partner of the patient may be either gender
* Age-matched female acquaintance is defined as within 5 years of age difference of the patient in younger group (18-45 years of age)
* With a similar level of education and race of the patient
* Not a personal friend of the patient
* No history of breast cancer
PATIENT CHARACTERISTICS:
* Must reside in the continental U.S. and speak English (for patients)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Gender
Female
Gender Based
false
Keywords
cognitive/functional effects
spiritual concerns
sexuality and reproductive issues
psychosocial effects of cancer and its treatment
cancer survivor
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
78 Years
Minimum Age
18 Years
NCT Id
NCT00309933
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
CDR0000460234
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Quality of Life in Younger Breast Cancer Survivors
Primary Outcomes
Outcome Measure
Comparison of the quality of life
Outcome Measure
Comparison of the quality of life of partners
Outcome Measure
Comparison of quality of life models
Outcome Measure
Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables
Secondary Ids
Secondary Id
ECOG-E2Z04
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
78
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joseph Sparano
Investigator Email
jsparano@montefiore.org
Investigator Phone
718-405-8404